Instructions for Use 

Name of Product

VISCOSEAL® SYRINGE

Sodium hyaluronate from fermentation 0.5%. Synovial fluid substitute. 10 ml pre-filled syringe in a sterile pack for single use. Sterile by moist heat.

 

COMPOSITION:

1 ml isotonic solution contains 5.0 mg sodium hyaluronate from fermentation, sodium chloride, disodium phosphate, sodium dihydrogen phosphate and water for injections.

INTENDED USE:

To relieve pain, improve mobility and promote joint recovery by flushing out irrigating solution and substituting the synovial fluid following arthroscopic procedures or joint lavage.

CONTRA-INDICATIONS:

Known hypersensitivity to any of the constituents of the product.

INteracTIONS:

No information on the incompatibility of VISCOSEAL® with other solutions for intra-articular use is available to date.

SIDE EFFECTS:

No undesirable effects are expected with VISCOSEAL® when used in the approved indication and at the dosage prescribed. The contra-indications must be considered.

Directions for use:

The contents and the outer surface of the VISCOSEAL® pre-filled syringe are sterile as long as the sterile pack remains unbroken. VISCOSEAL® should be used at the end of the arthroscopy after completion of the normal irrigating procedure. Take the pre-filled syringe out of the sterile pack. Remove the cap, attach a suitable needle and secure it by turning slightly. Alternatively, the pre-filled syringe may be placed directly into a portal in the joint. Remove any air bubble, if present, before introduction. Introduce VISCOSEAL® into the joint cavity. The introduction of VISCOSEAL® into the joint cavity will help to displace any remaining irrigation solution.

precautions:

The general precautions for arthroscopic procedures should be observed. VISCOSEAL® should be instilled accurately into the joint cavity. As VISCOSEAL® does not contain preservatives, any solution not used immediately after opening should be discareded. Do not use if the pre-filled syringe or the sterile pack are damaged. Store between 2º C and 25º C! Do not use after the expiry date indicated on the box. Keep out of the reach of children.

CHARACTERISTICS AND MODE OF ACTION:

Arthroscopy is a common procedure to visualise, diagnose and treat problems inside a joint. The joint is normally irrigated with solutions such as saline or Ringer lactate before and during arthroscopy in order to allow a clear view of the operation site and to rinse out debris. There is evidence that the presence of these solutions in the joint after irrigation may be detrimental to the cartilage. Furthermore, during the procedure the synovial fluid, which has particular viscoelastic and protective properties due to its hyaluronic acid content, is washed from the joint. Therefore, although the intervention may result in a long-term improvement of joint function, in the short-term patients may suffer from postarthroscopy complaints like pain, swelling and impaired mobility of the joint. VISCOSEAL® has been developed to relieve these symptoms and promote joint recovery. It contains a highly purified specific fraction of hyaluronic acid produced by fermentation and is devoid of animal protein. Instilling VISCOSEAL® into the joint cavity will help displace any remaining irrigating solution and efficiently coat all surfaces of the joint. VISCOSEAL ® will act as a lubricant and a shock absorber and its macromolecular meshwork will prevent the free passage of inflammatory cells and molecules through the joint cavity. In addition, hyaluronic acid is able to promote wound healing.

PRESENTATION:

1 pre-filled syringe of 50 mg/10 ml VISCOSEAL® in a sterile pack for single use.
To be used by a physician only.

Last revision date: July 2010.